An open-label observational study to examine the safety and efficacy of MediCabilis™ medicines for all indications
Introduction to the Bod Open-Label Observational Study (BodOLOS)
Patients eligible for medicinal cannabis in Australia may also be eligible for the Bod Open-Label Observational Study (BodOLOS) (ACTRN12620000741987).
BodOLOS is an open-label, longitudinal, Australia-wide, multi-centre observational study being conducted to assess the safety and efficacy of MediCabilis™ – our pharmaceutical-grade cannabis medicines – in patients undergoing medicinal cannabis therapy for any indication.
This study will collect data on safety and health outcomes on patients who have been prescribed MediCabilis™ for any indication for the duration of 12 months as part of routine care.
This information will improve evidence-based prescribing, help shape future clinical trials and help improve patient accessibility by supporting regulatory reform.
How can patients participate in the Observational Study?
Patients may be eligible to participate in this study if they are prescribed MediCabilis™ for any indication through one of the ethics-approved study sites.
Recruitment for this study must occur through ethics-approved study sites where medical doctors specialised in prescribing legal medical cannabis work closely with referring doctors and specialists in a shared-care model.
Patients may be eligible for treatment with medicinal cannabis if they fulfill the criteria set by the Therapeutic Goods Administration (TGA):
- They have a chronic medical condition
- All conventional approved treatment options have been considered and found unsuitable
- There is evidence to support the use of medicinal cannabis for your chronic condition
If you decide your patient may be an eligible candidate for this study, please refer your patient to one of the approved study sites listed below using our convenient referral form. The clinics will assess their eligibility and invite them to participate in the study if eligible.
- Ananda Clinics
- Australian Access Clinics
- Cannabis Access Clinics
- CDA Clinics
- Compass Lifestyle Clinics
- Tetra Health
Note: Please be aware that referral to these clinics will not guarantee that patients will be prescribed MediCabilis™ or be suitable to participate in the observational study. Patients should be aware that it is up to the discretion of the prescribing doctor to determine the most appropriate treatment options for a patient, which may or may not involve treatment with medicinal cannabis.
MediCabilis™ medicines have been approved for numerous conditions and indications including, but not limited to:
- Chronic pain
- Neuropathic pain
- Anxiety disorders including post-traumatic stress disorder (PTSD) or Social Anxiety Disorder (SAD)
- Autism Spectrum Disorder (ASD)
- Seizure management and epilepsy
- Parkinson’s disease and tremor management
- Palliative care
- Multiple sclerosis
- Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS)
Objectives of the study
The purpose of this study is to:
- Assess the safety and tolerability MediCabilis™ medicines that have been prescribed as a part of patient treatment plans
- Assess the efficacy of prescribed MediCabilis™ medicines for different indications
Information on MediCabilis™ Medicines
MediCabilis™ is Bod’s range of pharmaceutical-grade, cannabis-derived medicines.
MediCabilis™ medicines include a CBD-dominant full spectrum extract with very low levels of THC (< 0.2%) and plant-derived pure CBD isolates that contain no THC (0%).
They are high-quality medicines that are produced under stringent, international regulatory-compliant manufacturing processes to control for consistency of active ingredients and purity. Additionally, MediCabilis™ 5% CBD (LINNEA 315CSE™) was shown to be safe and well-tolerated in a Phase I clinical trial with no serious adverse events reported when administered acutely and repeatedly standardized to 50 mg CBD (1mL).
MediCabilis™ medicines are assessed with validated analytical techniques to evaluate the content of active ingredients and to test for impurities by affiliated laboratories and by independent third-party laboratories. The Therapeutic Goods Administration (TGA) has also begun analysing cannabis medicines to ensure they meet the same standards of quality and safety as approved – which the MediCabilis™ range has passed.
There are three MediCabilis™ medicines that will be assessed in this observational study. More information on the specific medicines can be found using the links below:
What does participation in this study involve for the patient?
As part of the observational study, de-identified information on patients’ health conditions and response to medicinal cannabis treatment will be collected before the beginning of treatment (baseline) and periodically as part of their routine care during the study period (12 months). As this is an observational study, there will be no intervention and does not require patients to make additional visits to clinics.
The types of information that will be collected as part of standard clinical assessment and during treatment include:
- Demographic data (e.g. age, gender)
- Medical history, clinical assessment and diagnoses of conditions
- Current medications
- MediCabilis™ medicine use (e.g. dose and frequency)
- Any potential adverse events
- Patient-reported outcomes (questionnaires)
Who is eligible to participate in the observational study?
Patients who have been prescribed MediCabilis™ through an approved study site for any indication may be eligible to participate in this study.
- Persons of any gender, age equal or greater than 18 years.
- Prospective patients that can understand the informed consent process and to give informed consent to participate in the study.
- Diagnosis of their condition/disease confirmed by the patient’s GP or specialist.
- Patients have been lawfully prescribed MediCabilis™ by their consenting doctor for the treatment of their condition.
- Prospective participants agree to abstain from using illicit cannabis for the duration of their participation in the study. Other prescribed cannabis medicines are permitted.
- Any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant’s ability to provide informed consent
What are the costs and benefits of participating in the study?
As participation in this study has to occur through an approved study site, the costs that occur for consulting a doctor at an approved medicinal cannabis clinic still apply and are the responsibility of the patient.
Consultation fees vary for each clinic. Doctors and patients are encouraged to contact the study sites directly to find the most suitable site for their needs.
Patients who participate in this observational study will receive:
- Two complimentary 25 mL MediCabilis™ medicines towards their treatment
- Reduced pricing for MediCabilis™ medicines used for the duration of the study
- Access to easy and convenient patient reporting software that will track their progress
Treatment with cannabis medicines has improved medical conditions and quality of life for many patients who were unsuccessful with standard treatment options. Some patients may experience improvement in their medical conditions and quality of life by accessing medicinal cannabis through this study.
Additionally, participation in this study will collect important scientific knowledge that will add to the evidence base around medicinal cannabis. This may assist with the better utilisation of cannabis medicines and the development of new medications for improved treatment of patients with similar conditions.
Doctors will be able to easily monitor the progress of their patients’ conditions through the validated and systematic collection of patient data, which will be available to all participating doctors.
Specific details on the study can be found on the Australian New Zealand Clinical Trials Registry (ANZCTR) site (ACTRN12620000741987).
If you have any additional questions, please contact us here.